FDA Device recall Z-1757-2023

CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1757-2023
Classification	Class I
Status	ongoing
Initiated	2023-05-10
Published	2023-06-28
Last updated	2026-09-13 11:56 UTC
Company	Medtronic Cardiac Rhythm And Heart Failure Crhf
Distribution	US

Product

CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators

Reason

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Identifiers

code_info	GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO60… GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S

code_info

GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO60…

GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1757-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.